Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance

NCT02161471 | Completed

• 1 other identifier: Atrial function in CHD by CMR
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether patients with repaired congenital heart disease show differences in size or function of their heart atria compared to normal controls and depending on the nature of their heart disease.

Conditions

Coarctation of the Aorta; Tetralogy of Fallot; Transposition of the Great Arteries

Keywords

Atria, Heart; Function, Atrial; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Tetralogy, Fallot; Transposition of Great Arteries; Coarctation of the Aorta

Outcome Measures

Primary Outcomes (1)

• Right and left atrial volume

  Measurement of maximal volume (at end of systole), volume before atrial contraction (in late diastole), and minimal volume (at end of diastole) of both atria.

  Day of CMR (baseline only, no intervention)

Secondary Outcomes (1)

• Blood flow across the atrio-ventricular valves

  Day of CMR (baseline only, no intervention)

Study Arms (2)

Tetralogy of Fallot

Patients after repair of tetralogy of Fallot

Normal

Normal controls

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants for the study will be recruited among patients, children and adults, with CHD (groups 1-4) undergoing cardiac magnetic resonance examination for clinical reasons. 1. Patients after repair of coarctation of the aorta 2. Patients after repair of tetralogy of Fallot 3. Patients with transposition of the great arteries after atrial switch (Senning procedure) 4. Patients with transposition of the great arteries after arterial switch operation 5. Children without cardiovascular anomalies undergoing CMR for other clinical reasons not influencing cardiac function (control group)

You may qualify if:

• Ability to perform repetitive breath holds of 10-15 seconds each
• Written informed consent of the patients or their legal guardians

You may not qualify if:

• Patients requiring general anaesthesia
• Residual cardiac findings which might potentially influence the size and function of the atria

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital Zürich, Switzerland

Zurich, Canton of Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Aortic Coarctation; Tetralogy of Fallot; Transposition of Great Vessels; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Heart Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Emanuela R Valsangiacomo Buechel, Prof.

  University Children's Hospital Zürich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 11, 2014
• Study Start: June 16, 2009
• Primary Completion: November 24, 2009
• Study Completion: November 24, 2009
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

CH (1)